ALFUZOSIN HYDROCHLORIDE tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ALFUZOSIN HYDROCHLORIDE (UNII: 75046A1XTN) (ALFUZOSIN - UNII:90347YTW5F)

Available from:

Exelan Pharmaceuticals Inc.

INN (International Name):

ALFUZOSIN HYDROCHLORIDE

Composition:

ALFUZOSIN HYDROCHLORIDE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Alfuzosin hydrochloride tablets, USP are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. Alfuzosin hydrochloride is not indicated for the treatment of hypertension. Alfuzosin hydrochloride is not indicated for use in the pediatric population. Alfuzosin hydrochloride is contraindicated for use: - in patients with moderate or severe hepatic impairment (Childs-Pugh categories B and C), since alfuzosin blood levels are increased in these patients [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)] . - with potent CYP3A4 inhibitors such as ketoconazole, itraconazole, and ritonavir, since alfuzosin blood levels are increased [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)] . - in patients with known hypersensitivity, such as urticaria and angioedema, to alfuzosin hydrochloride or any component of alfuzosin hydrochloride tablets [see Adverse Reactions (6.2)] . Risk Summary Alfuzosin hydrochloride extended-release tablets is not indicated for use

Product summary:

Alfuzosin hydrochloride extended-release tablets, USP 10 mg are available as off white, round, biconvex tablets debossed with 'IG' on one side and "302" on other. Alfuzosin hydrochloride Extended-Release tablets are supplied as follows: Package  NDC Number Bottles of 90               76282-302-90 Bottles of 100             76282-302-01 Bottles of 120             76282-302-12 Bottles of 500             76282-302-05 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP. Keep alfuzosin hydrochloride out of reach of children.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ALFUZOSIN HYDROCHLORIDE - ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED
RELEASE
EXELAN PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ALFUZOSIN HYDROCHLORIDE
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ALFUZOSIN
HYDROCHLORIDE.
ALFUZOSIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, USP FOR ORAL USE
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
Alfuzosin hydrochloride extended-release tablets USP, is an alpha
adrenergic antagonist, indicated for
treatment of signs and symptoms of benign prostatic hyperplasia. (1)
Important Limitations of Use:
Alfuzosin hydrochloride is not indicated for the treatment of
hypertension. (1.1)
Alfuzosin hydrochloride is not indicated for use in the pediatric
population. (1.1, 8.4, 12.3)
DOSAGE AND ADMINISTRATION
10 mg once daily with food and with the same meal each day (2)
Tablets should not be chewed or crushed (2, 12.3)
DOSAGE FORMS AND STRENGTHS
Extended-release tablet: 10 mg (3)
CONTRAINDICATIONS
Moderate or severe hepatic impairment (4, 8.7, 12.3)
Co-administration with potent CYP3A4 inhibitors (e.g. ketoconazole,
itraconazole, ritonavir) (4, 5.4, 7.1,
12.3)
Known hypersensitivity (e.g., urticaria or angioedema) to alfuzosin or
any of the ingredients (4, 6.2)
WARNINGS AND PRECAUTIONS
Postural hypotension/syncope: Care should be taken in patients with
symptomatic hypotension or who
have had a hypotensive response to other medications or are
concomitantly treated with
antihypertensive medication or nitrates (5.1)
Use with caution in patients with severe renal impairment (creatinine
clearance <30 mL/min) (5.2, 8.6,
12.3)
Use with caution in patients with mild hepatic impairment (5.3, 8.7,
12.3)
Should not be used in combination with other alpha adrenergic
antagonists (5.4, 7.2)
Prostate carcinoma should be ruled out prior to treatment (5.5)
Intraoperative Floppy Iris Syndrome (IFIS) during cataract surgery may
require modifications to the
surgical technique (5.6)
Discontinue alfuzosin